Nucleic acid test cassette

Abstract

The present application relates to the field of in-vitro diagnosis in biotechnologies, and, for example, relates to a nucleic acid test cassette (1000). The nucleic acid test cassette (1000) comprises an upper case (100), a lower case (200), a reaction tube (300), a liquid storage tube (400), a liquid pushing rod (500), a rotary sealing plug (600) and a reagent strip (700). The upper case (100) and the lower case (200) jointly form the cassette. The reaction tube (300), the liquid storage tube (400), the liquid pushing rod (500) and the reagent strip (700) are all arranged on the cassette. The reaction tube (300) is provided with a liquid inlet (310) and a liquid outlet (320). The liquid pushing rod (500) can drive a reagent in the liquid storage tube (400) to enter the reaction tube (300) through the liquid inlet (310), and the liquid pushing rod (500) can also drive the reagent in the reaction tube (300) to flow into the reagent strip (700) through the liquid outlet (320). The reagent strip (700) is configured to display a test result. A freeze-dried ball reacted with the reagent and a sample to be tested all can be introduced into the reaction tube (300) through an opening in the reaction tube (300). The rotary sealing plug (600) is configured to seal the opening, and can control the liquid inlet (310) to be opened and blocked and control the liquid outlet (320) to be opened and blocked, so as to fully react the reagent, the freeze-dried ball and said sample in the reaction tube (300) and enable a test on the reacted reagent.

Description

Nucleic acid test cartridge

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on December 11, 2023, with application number 202323357691.4, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application relates to the field of in vitro diagnostic biotechnology, for example, to a nucleic acid detection cartridge. Background Art

[0003] Polymerase Chain Reaction (PCR) nucleic acid testing uses a segment of deoxyribonucleic acid (DNA) as a template. With the participation of DNA polymerase and nucleotide substrates, the DNA segment is amplified to a sufficient amount for structural and functional analysis.

[0004] In the relevant technology, PCR nucleic acid detection equipment is large in size and weight, the sample processing process is cumbersome, and the detection time is long (usually the detection time is more than three hours). Conventional PCR nucleic acid detection equipment is only suitable for high-throughput nucleic acid detection in standard laboratories. Due to the high sample processing conditions for PCR nucleic acid detection in conventional PCR nucleic acid detection equipment, the difficulty of miniaturization of fluorescence detection technology, and the high cost of sample transportation (cold chain transportation is required), the mobile nucleic acid detection method is still in the research and development stage. The mature in vitro diagnostic technology is still the antigen detection method, but the antigen detection has lower sensitivity than the nucleic acid detection and poor detection effect. For clinical in vitro diagnosis, it can only be used as an auxiliary screening method and cannot be used as a diagnostic standard.

[0005] Summary of the Invention

[0006] The purpose of this application is to provide a nucleic acid detection card box to achieve rapid amplification and detection of samples and reaction reagents. It can be used for mobile detection such as home self-testing and bedside testing. It has simple operation, low detection cost and high detection accuracy.

[0007] To achieve this goal, this application adopts the following technical solutions:

[0008] Nucleic acid detection cartridge, including:

[0009] An upper shell and a lower shell, wherein the upper shell and the lower shell together form a card box;

[0010] A reaction tube, a liquid storage tube, a liquid push rod, a rotary sealing plug and a reagent strip; the reaction tube, the liquid storage tube, the liquid push rod and the reagent strip are all arranged on the cartridge;

[0011] The reaction tube is provided with a liquid inlet and a liquid outlet, and the push rod can drive the reagent in the liquid storage tube to enter the reaction tube along the liquid inlet, and the push rod can also drive the reagent in the reaction tube to flow along the liquid outlet onto the reagent strip, and the reagent strip is configured to display the test results;

[0012] The freeze-dried balls that react with the reagent and the sample to be tested can be placed into the reaction tube along the opening on the reaction tube. The rotary sealing plug is configured to seal the opening. The rotary sealing plug can control the conduction and blocking of the liquid inlet and the conduction and blocking of the liquid outlet.

[0013] As an optional solution, a movable plug is provided on the open end of the liquid storage tube away from the liquid inlet, and the reagent is sealed and stored at the end of the movable plug close to the liquid inlet. The movable plug is connected to the pushing rod, and the pushing rod can push the movable plug to move toward the liquid inlet.

[0014] As an optional solution, the nucleic acid detection cartridge further includes:

[0015] A driving assembly is connected to the liquid pushing rod, and the driving assembly can drive the liquid pushing rod to move relative to the liquid storage tube toward the liquid inlet.

[0016] As an optional solution, the drive assembly includes:

[0017] a rotary drive member; and

[0018] A docking gear is provided on the push rod and is provided with a docking rack arranged along the extension direction of the push rod. The rotary drive member is connected to the docking gear, and the docking gear is meshed with the docking rack. The rotary drive member can drive the docking gear to rotate.

[0019] As an optional solution, a liquid inlet guide groove and a liquid outlet guide groove are provided on the rotary sealing plug, and the rotary sealing plug can rotate relative to the reaction tube to connect or disconnect the liquid inlet guide groove and the liquid outlet guide groove to connect or disconnect the liquid outlet.

[0020] As an optional solution, an indicator is further provided on the rotary sealing plug, and the indicator can provide an indication of whether the liquid inlet guide groove is connected to the liquid inlet and whether the liquid outlet guide groove is connected to the liquid outlet.

[0021] As an optional solution, the nucleic acid detection cartridge further includes:

[0022] A flow guide tube, one end of which is connected to the liquid outlet, and the other end of which is connected to the reagent strip.

[0023] As an optional solution, the guide tube, the reaction tube and the liquid storage tube are integrally formed.

[0024] As an optional solution, an observation window is provided on the upper shell, and the observation window is directly opposite to the reagent strip.

[0025] As an optional solution, the inner cavity surface of the upper shell is provided with a downward extending fixing column, the inner cavity surface of the lower shell is provided with an upward extending docking column, the upper end surface of the docking column is provided with a downward extending fixing hole, and the fixing column is plugged and fixed into the fixing hole. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG1 is an exploded view of a nucleic acid detection cartridge provided in an embodiment of the present application;

[0027] FIG2 is a schematic diagram of the structure of a reaction tube, a liquid storage tube, and a flow guide tube provided in an embodiment of the present application;

[0028] FIG3 is a schematic cross-sectional view of section AA in FIG2 ;

[0029] FIG4 is a second schematic structural diagram of a reaction tube, a liquid storage tube, and a flow guide tube provided in an embodiment of the present application;

[0030] FIG5 is a schematic cross-sectional view of section BB in FIG4 .

[0031] In the figure: 1000, nucleic acid detection cartridge; 100, upper shell; 110, observation window; 200, lower shell; 210, docking column; 211, fixing hole; 212 fixing column; 300, reaction tube; 310, liquid inlet; 320, liquid outlet; 400, liquid storage tube; 410, movable plug; 500, push rod; 510, docking rack; 600, rotary sealing plug; 610, indicator; 620, liquid inlet guide groove; 630, liquid outlet guide groove; 700, reagent strip; 800, guide tube; 810, sealing tube; 900, docking gear; 910, rotating drive member; 920, drive assembly. DETAILED DESCRIPTION

[0032] The technical solution of this application is explained below with reference to the accompanying drawings and through specific implementation methods.

[0033] In the description of this application, unless otherwise clearly specified and limited, the terms "connected", "connected" and "fixed" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements.

[0034] In this application, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Furthermore, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0035] In the description of this embodiment, the terms "upper," "lower," "left," and "right," etc., regarding orientations or positions, are based on the orientations or positions shown in the accompanying drawings and are intended solely for ease of description and simplified operation. They do not indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first" and "second" are used solely for descriptive purposes and have no special meanings.

[0036] In the relevant technology, PCR nucleic acid detection equipment is large in size and weight, the sample processing process is cumbersome, and the detection time is long (usually the detection time is more than three hours). Conventional PCR nucleic acid detection equipment is only suitable for high-throughput nucleic acid detection in standard laboratories. Due to the high sample processing conditions for PCR nucleic acid detection in conventional PCR nucleic acid detection equipment, the difficulty of miniaturization of fluorescence detection technology, and the high cost of sample transportation (cold chain transportation is required), the mobile nucleic acid detection method is still in the research and development stage. The mature in vitro diagnostic technology is still the antigen detection method, but the antigen detection has lower sensitivity than the nucleic acid detection and poor detection effect. For clinical in vitro diagnosis, it can only be used as an auxiliary screening method and cannot be used as a diagnostic standard.

[0037] As shown in Figure 1, this embodiment provides a nucleic acid detection cartridge 1000. The nucleic acid detection cartridge 1000 includes an upper shell 100, a lower shell 200, a reaction tube 300, a liquid storage tube 400, a liquid pusher 500, a rotary sealing plug 600, and a reagent strip 700. The upper shell 100 and the lower shell 200 together constitute a cartridge. The reaction tube 300, the liquid storage tube 400, the liquid pusher 500, and the reagent strip 700 are all arranged on the cartridge. The reaction tube 300 is provided with a liquid inlet 310 and a liquid outlet 320. The liquid pusher 500 can drive the reagent strip 700 in the liquid storage tube 400. The reagent enters the reaction tube 300 along the liquid inlet 310, and the push rod 500 can also drive the reagent in the reaction tube 300 to flow along the liquid outlet 320 onto the reagent strip 700. The reagent strip 700 is configured to display the test results. The freeze-dried balls that react with the reagent and the samples to be tested can be placed into the reaction tube 300 along the opening on the reaction tube 300. The rotary sealing plug 600 is configured to seal the opening. The rotary sealing plug 600 can control the conduction and blocking of the liquid inlet 310 and the conduction and blocking of the liquid outlet 320.

[0038] The nucleic acid detection cartridge 1000 places the freeze-dried balls and the detection sample into the reaction tube 300 along the opening of the reaction tube 300, then seals the opening with a rotary sealing plug 600, and connects the liquid inlet 310. The push rod 500 injects the reagent in the liquid storage tube 400 into the reaction tube 300, and then the liquid inlet 310 is blocked, so that the freeze-dried balls, the sample to be detected and the reagent in the reaction tube 300 react. After the reaction is completed, the liquid outlet 320 is connected, and the push rod 500 is used to flow the reagent in the reaction tube 300 along the liquid outlet 320 into the reagent strip 700. The test result is displayed on the reagent strip 700, thereby realizing the detection of the sample to be detected. The operation steps are simple, and no large instruments and standard laboratories are required. It can be applied to mobile detection such as home self-testing and bedside detection, thereby reducing the detection cost, having high detection accuracy and high applicability.

[0039] Furthermore, by mixing the lyophilized beads with the reagents to form the test solution, the storage and transportation issues of the test solution at room temperature are resolved, eliminating the cold chain transportation costs of the detector and further reducing testing costs. The lyophilized beads contain primer probes, magnesium acetate, and other substances to ensure amplification of the fusion reaction between the sample and the reagent. The specific composition and reaction principle of the lyophilized beads are well-known technologies and will not be elaborated here.

[0040] Optionally, an oscillating heater may be provided in the nucleic acid detection cartridge 1000 , and the reaction tube 300 may be placed in the oscillating heater. By oscillating and heating the reaction tube 300 , the amplification efficiency of the DNA in the reagent may be improved.

[0041] As shown in Figures 2 to 5, a movable plug 410 is provided on the open end of the liquid storage tube 400 away from the liquid inlet 310. The reagent is sealed and stored at the end of the movable plug 410 near the liquid inlet 310. The movable plug 410 is connected to a liquid push rod 500, which can push the movable plug 410 toward the liquid inlet 310. By providing the movable plug 410 at the open end of the liquid storage tube 400, the reagent is accommodated at the end of the movable plug 410 near the liquid inlet 310, thereby achieving sealed storage of the reagent. The movable plug 410 is pushed toward the liquid inlet 310 by the liquid push rod 500, thereby driving the reagent accommodated at the end of the movable plug 410 near the liquid inlet 310 along the liquid inlet 310 into the reaction tube 300.

[0042] Optionally, the nucleic acid detection cartridge 1000 further includes a drive assembly (920), wherein the drive assembly (920) is connected to the push rod 500, and the drive assembly (920) is capable of driving the push rod 500 to move relative to the liquid storage tube 400 toward the direction close to the liquid inlet 310. By setting the drive assembly (920), the push rod 500 is driven to move relative to the liquid storage tube 400 toward the direction close to the liquid inlet 310, thereby driving the movable plug 410 to move toward the direction close to the liquid inlet 310.

[0043] As shown in Figure 1, the drive assembly (920) includes a rotary drive member (910) and a docking gear 900, wherein the push rod 500 is provided with a docking rack 510 arranged along the extension direction of the push rod 500, the rotary drive member (910) is connected to the docking gear 900, and the docking gear 900 is meshed with the docking rack 510, and the rotary drive member (910) can drive the docking gear 900 to rotate. The docking gear 900 is driven to rotate by the rotary drive member (910), and then the docking rack 510 meshed with the docking gear 900 is driven to move, thereby realizing the effect of driving the mobile plug 410 to move in the direction close to the liquid inlet 310. In the present embodiment, the rotary drive member (910) is a rotary motor. The rotary motor has a simple structure and is sensitive to reaction. In other embodiments, the rotary drive member (910) can also be other rotary drive members, and the present embodiment is not specifically limited. In addition, the rotating drive member (910) can be removed, and the docking gear 900 can be exposed outside the box body composed of the upper shell 100 and the lower shell 200. The operator can manually drive the docking gear 900 to rotate, thereby simplifying the structure of the nucleic acid detection card box 1000.

[0044] As shown in Figures 3 and 5, a liquid inlet guide groove 620 and a liquid outlet guide groove 630 are provided on the rotary sealing plug 600. The rotary sealing plug 600 can rotate relative to the reaction tube 300 to connect or disconnect the liquid inlet guide groove 620 and the liquid inlet port 310, and to connect or disconnect the liquid outlet guide groove 630 and the liquid outlet port 320.

[0045] When the reagent in the liquid storage tube 400 needs to be transferred to the reaction tube 300, first, the rotary sealing plug 600 is screwed relative to the reaction tube 300 so that the liquid inlet guide groove 620 in the rotary sealing plug 600 is aligned with the liquid inlet 310 and the liquid outlet guide groove 630 is aligned with the liquid outlet 320, thereby achieving the conduction between the liquid inlet 310 and the liquid outlet 320. Then, the rotary driving member (910) is started to drive the docking gear 900 to rotate, thereby driving the push rod 500 toward the reaction tube 300. Move in the direction of the liquid inlet 310, the reagent in the liquid storage tube 400 will flow into the reaction tube 300 along the liquid inlet 310, ensuring that the liquid level of the reagent in the reaction tube 300 is lower than the level of the liquid outlet 320, stop the rotating driving member (910) and screw the rotary sealing plug 600, so that the liquid inlet guide groove 620 is no longer connected to the liquid inlet 310, and the rotary sealing plug 600 blocks the liquid inlet 310 again, thereby achieving the effect of transferring the reagent in the liquid storage tube 400 to the reaction tube 300.

[0046] When the reagent in the reaction tube 300 needs to be transferred to the reagent strip 700, the rotary sealing plug 600 is first screwed relative to the reaction tube 300 so that the liquid inlet guide groove 620 in the rotary sealing plug 600 is aligned with the liquid inlet 310 and the liquid outlet guide groove 630 is aligned with the liquid outlet 320, thereby achieving the conduction of the liquid inlet 310 and the conduction of the liquid outlet 320. Then, the rotary driving member (910) is started to drive the docking gear 900 to rotate, thereby driving the push rod 500 to move toward the liquid inlet 310, and the liquid storage The reagent in the tube 400 will flow into the reaction tube 300 along the liquid inlet 310, and the reagent in the reaction tube 300 will flow out along the liquid outlet 320 and be transferred to the reagent strip 700. The rotating driving member (910) is stopped and the rotary sealing plug 600 is screwed so that the liquid inlet guide groove 620 is no longer connected to the liquid inlet 310, and the liquid outlet guide groove 630 is no longer directly opposite to the liquid outlet 320. The rotary sealing plug 600 blocks the liquid inlet 310 and the liquid outlet 320 again, thereby achieving the effect of transferring the reagent in the reaction tube 300 to the reagent strip 700.

[0047] In this embodiment, the height of the liquid inlet 310 is the same as the height of the liquid outlet 320. In other embodiments, the height of the liquid outlet 320 may be higher than the height of the liquid inlet 310, which is not specifically limited in this embodiment.

[0048] To improve the accuracy of the conduction and blocking of the rotary sealing plug 600 with respect to the liquid inlet 310 and the liquid outlet 320, an indicator 610 is provided on the rotary sealing plug 600. The indicator 610 can indicate whether the liquid inlet guide groove 620 is in conduction with the liquid inlet 310 and whether the liquid outlet guide groove 630 is in conduction with the liquid outlet 320. The provision of the indicator 610 makes it easier for staff to determine whether the rotary sealing plug 600 has blocked the liquid inlet 310 and the liquid outlet 320, thereby improving the ease of use of the nucleic acid detection cartridge 1000.

[0049] Optionally, the nucleic acid detection cartridge 1000 further includes a flow guide tube 800, wherein one end of the flow guide tube 800 is in communication with the liquid outlet 320, and the other end of the flow guide tube 800 is connected to the reagent strip 700. The provision of the flow guide tube 800 can improve the transfer accuracy of the reagent from the liquid outlet 320 to the reagent strip 700, and can also ensure that the reagent is prevented from contacting the outside air, thereby improving the protection of the reagent.

[0050] In addition, in this embodiment, a sealing tube 810 is provided on the outer periphery of the flow guide tube 800 , and the sealing tube 810 is used to wrap the flow guide tube 800 to improve the protection of the reagent.

[0051] The flow guide tube 800, the reaction tube 300, and the liquid storage tube 400 are integrally formed. By integrally forming the flow guide tube 800, the reaction tube 300, and the liquid storage tube 400, the production efficiency of the nucleic acid detection cartridge 1000 can be improved.

[0052] The specific structure of the upper shell 100 and the lower shell 200 is described in conjunction with Figure 1. The inner cavity surface of the upper shell 100 is provided with a downwardly extending fixing column (212), and the inner cavity surface of the lower shell 200 is provided with an upwardly extending docking column 210. The upper end surface of the docking column 210 is provided with a downwardly extending fixing hole 211, and the fixing column (212) is plugged and fixed with the fixing hole 211. By providing the downwardly extending fixing column (212) on the inner cavity surface of the upper shell 100 and the upwardly extending docking column 210 on the inner cavity surface of the lower shell 200, and providing the downwardly extending fixing hole 211 on the upper end surface of the docking column 210, the upper shell 100 and the lower shell 200 are assembled and fixed by plugging and fixing the fixing column (212) with the fixing hole 211.

[0053] A plurality of fixing posts (212) are arranged at equal intervals on the upper shell 100, and a plurality of docking posts 210 are arranged at equal intervals on the lower shell 200. A fixing hole 211 is provided in each docking post 210, and each fixing hole 211 is arranged correspondingly to a fixing post (212) to improve the fixing effect of the upper shell 100 and the lower shell 200.

[0054] In addition, to facilitate observation of test information, an observation window 110 is provided on the upper housing 100, which is directly opposite the reagent strip 700. When the operator needs to observe the test information of the sample to be tested, the test strip 700 can be directly observed through the observation window 110, which improves the observation convenience.

Claims

1. A nucleic acid detection cartridge, comprising: An upper shell (100) and a lower shell (200), wherein the upper shell (100) and the lower shell (200) together form a card box; A reaction tube (300), a liquid storage tube (400), a liquid pushing rod (500), a rotary sealing plug (600) and a reagent strip (700); the reaction tube (300), the liquid storage tube (400), the liquid pushing rod (500) and the reagent strip (700) are all arranged on the cartridge; The reaction tube (300) is provided with a liquid inlet (310) and a liquid outlet (320); the liquid push rod (500) can drive the reagent in the liquid storage tube (400) to enter the reaction tube (300) along the liquid inlet (310); the liquid push rod (500) can also drive the reagent in the reaction tube (300) to flow along the liquid outlet (320) onto the reagent strip (700); the reagent strip (700) is configured to display the test result; The freeze-dried balls that react with the reagent and the sample to be tested can be placed in the reaction tube (300) along the opening on the reaction tube (300), and the rotating sealing plug (600) is configured to seal the opening. The rotating sealing plug (600) can control the conduction and blocking of the liquid inlet (310) and the conduction and blocking of the liquid outlet (320).

2. The nucleic acid detection cartridge according to claim 1, wherein: A movable plug (410) is provided on the open end of the liquid storage tube (400) away from the liquid inlet (310), and the reagent is sealed and stored at the end of the movable plug (410) close to the liquid inlet (310). The movable plug (410) is connected to the liquid pushing rod (500), and the liquid pushing rod (500) can push the movable plug (410) to move in a direction close to the liquid inlet (310).

3. The nucleic acid detection cartridge according to claim 2, further comprising: A driving assembly (920), wherein the driving assembly (920) is connected to the liquid pushing rod (500), The driving assembly (920) is capable of driving the liquid pushing rod (500) to move relative to the liquid storage tube (400) toward a direction approaching the liquid inlet (310).

4. The nucleic acid detection cartridge according to claim 3, wherein: The drive assembly (920) comprises: a rotary drive member (910); and A docking gear (900), a docking rack (510) arranged along the extension direction of the push rod (500) is provided on the push rod (500), the rotating drive member (910) is connected to the docking gear (900), the docking gear (900) is meshed with the docking rack (510), and the rotating drive member (910) can drive the docking gear (900) to rotate.

5. The nucleic acid detection cartridge according to any one of claims 1 to 4, wherein: The rotary sealing plug (600) is provided with a liquid inlet guide groove (620) and a liquid outlet guide groove (630), and the rotary sealing plug (600) can rotate relative to the reaction tube (300) to connect or disconnect the liquid inlet guide groove (620) and the liquid inlet port (310), and to connect or disconnect the liquid outlet guide groove (630) and the liquid outlet port (320).

6. The nucleic acid detection cartridge according to claim 5, wherein: The rotary sealing plug (600) is also provided with an indicator (610), and the indicator (610) can provide an indication of whether the liquid inlet guide groove (620) is in communication with the liquid inlet port (310) and whether the liquid outlet guide groove (630) is in communication with the liquid outlet port (320).

7. The nucleic acid detection cartridge according to any one of claims 1 to 4, further comprising: A flow guide tube (800), one end of which is in communication with the liquid outlet (320), and the other end of which is connected to the reagent strip (700).

8. The nucleic acid detection cartridge according to claim 7, wherein: The flow guide tube (800), the reaction tube (300) and the liquid storage tube (400) are integrally formed.

9. The nucleic acid detection cartridge according to any one of claims 1 to 4, wherein: An observation window (110) is provided on the upper shell (100), and the observation window (110) is directly opposite to the reagent strip (700).

10. The nucleic acid detection cartridge according to any one of claims 1 to 3, wherein: The inner cavity surface of the upper shell (100) is provided with a downwardly extending fixing column (212), the inner cavity surface of the lower shell (200) is provided with an upwardly extending docking column (210), the upper end surface of the docking column (210) is provided with a downwardly extending fixing hole (211), and the fixing column (212) is plugged and fixed to the fixing hole (211).

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